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1 Clinical Trial Details (PDF Generation Date :- Wed, 10 Apr :29:54 GMT) CTRI Number Last Modified On 24/08/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 28/05/2012] - Trial Registered Retrospectively No Interventional Biological Single Arm Trial Long-term Extension Study to Evaluate the Safety and Efficacy of Daclizumab High Yield Process A Multicenter, Open-label, Extension Study to Evaluate the Long term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) EudraCT 205MS203 dated 17 June 2011, version 2 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Source of Monetary or Material Support > Idec Ltd. Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom Type of Sponsor Idec Primary Sponsor Details Idec Ltd. Innovation House, 70 Norden Road, Maidenhead Berkshire SL6 4AY,United Kingdom (UK) Pharmaceutical industry-global Idec Biotech Pvt Ltd 14th Floor, Block -B, Vatika Towers, Sector - 54, Golf course road, , Haryana, List of Countries Czech Republic Germany Hungary Poland Russian Federation Ukraine United Kingdom of Principal Investigator of Site Site Phone// Dr Rajaram Agrawal Brain Care Brain Care Room: A 195 Vidyut Nagar Prince Road Ajmer Road Jaipur Jaipur RAJASTHAN Dr Kanikannan Meena Dr Sangeeta Ravat Dr Pahari Ghosh Nizams Institute of Medical Sciences Seth G S Medical College and KEM Hospital Sri Aurobindo Seva Kendra Nizams Institute of Medical Sciences, Room No. 329 A, Millennium Block, Punjagutta Hyderabad Hyderabad ANDHRA PRADESH Seth G S Medical College and KEM Hospital Ward No nd floor Old building Acharya Dhonde Marg Parel Mumbai Mumbai (Suburban) MAHARASHTRA Sri Aurobindo Seva Kendra Department of Neurology, Room:1H, drrajaram195@rediffma il.com meenaak@hotmail.com ravatsh@yahoo.com ghosh.pahari@gmail.co page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr Thomas Mathew St Johns Medical College Hospital Gariahat Road Kolkata Kolkata WEST BENGAL St Johns Medical College and Hospital, Third floor, Room No 3, Sarjapur Road Kormangala Bangalore Bangalore KARNATAKA m chakkuthom@hotmail.c om of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee for Research on Human Subject Institutional Ethical Review Board St Johns Medical College Hospital Sarjapur Road Kormangala Bangalore Karnataka Institutional Ethics Committee, Nizam s Institute of Medical Sciences, Millennium Block, Panjagutta, Hyderabad , Andhra Pradesh, Swastik Ethics Committee, Laxmi Villa, B- 15/5, Shiv Marg, Bani Park, Jaipur , Rajasthan, The Ethics Committee of Sri Aurobindo Seva Kendra, Department of Neurology, 1H, Gariahat Road, Kolkata ,. Status Approved 16/05/2012 No Approved 30/01/2012 No Approved 02/12/2011 No Approved 23/12/2011 No Approved 25/10/2011 No Date Approved/Obtained 07/05/2012 Health Type Patients Condition Relapsing-Remitting Multiple Sclerosis (RRMS) Type Details Intervention Daclizumab High Yield Process (DAC HYP) Comparator Agent Age From Age To Year(s) Year(s) Inclusion Criteria DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for 144 weeks page 3 / 5

4 Gender Details Both 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations. 2. Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator. 3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment. Exclusion Criteria Details Exclusion Criteria 1. Subjects with any significant change in their medical status from the previous study that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject s participation in the 205MS201 or 205MS202 studies. The Investigator must re review the subject s medical fitness for participation and must consider any diseases that would preclude treatment. 2. Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE. 3. Current enrollment in any investigational drug study other than Study 205MS Ongoing treatment with any approved or experimental disease-modifying treatment for MS. 5. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject s ability to comply with the protocol. Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints The primary objective of this study is to assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMS 144 weeks Secondary Outcome Outcome Timepoints The secondary objectives of this study are to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing MS relapse, slowing disability progression, and reducing new MS lesion formation in this study population. Immunogenicity Sustained disability progression defined by at least a 1.0-point increase on the EDSS from a baseline EDSS?1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS 1.0 that is sustained for 12 weeks Annual change in total number and volume of new or newly enlarging T2 hyperintense lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI ARR Target Sample Size Total Sample Size=450 Sample Size from =12 page 4 / 5

5 Powered by TCPDF ( Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 19/01/ /03/2010 Years=2 Months=5 Days=0 Completed Completed All subjects will receive one DAC HYP 150 mg SC injection every 4 weeks. After the first 12 weeks in this study, subjects will have the option of administering DAC HYP at home. Subjects who are not able to administer their own dose or prefer not to administer their own dose of DAC HYP will be given the option to choose another individual to administer their treatment or to have their treatment administered by staff at the study site. A protocol-defined futility analysis in the 205MS201 study did not find evidence of futility at the proposed dose of DAC HYP, which was originally selected based on the findings of the completed Phase 2 DAC-1012 study. Additionally, the ongoing safety review of the 205MS201 and 205MS202 studies supports continued dosing and initiation of home dosing for subjects who have previously tolerated DAC HYP dosing in the clinic. Prior to self-administration of DAC HYP as an SC injection in this study, subjects will have received DAC HYP for a minimum of 15 months and a maximum of 27 months comprising their treatment in the 205MS201 and 205MS202 studies plus the first 3 months of observed therapy in the current study. page 5 / 5